After ostomy surgical procedures, it is necessary for the patient to wear an appliance to collect the fluid discharged from the stoma which has been surgically formed at the abdominal wall of the patient. Such appliances commonly include a flexible pouch for collecting urine which is discharged from the stoma. There has been some difficulty with prior art devices in that the fluid as it collects within the pouch can splash or flow upwardly into the stoma as the patient moves about. This can cause skin irritation and/or infection.
In one type of drainage appliance constructed to avoid this problem, the pouch is formed of four superimposed layers of flexible sheet material. The two outside sheets form the outside of the pouch while the two inside sheets extend only across the upper section of the pouch. The sheets are all sealed together about their periphery to form the pouch and an inlet opening is provided in the upper section to provide communication with the space between the inside sheets. Drainage fluid from the stoma is received through this inlet opening and collects in the lower section of the pouch. To deter backward splashing or flow of fluid to the upper section of the pouch, the two internal sheets are sealed along a zone spaced from and extending generally along their lower edges, these edges extending across the center of the pouch. The sealing provides the necessary mechanism for permitting the lower edges of the inner sheets to function as a type of flutter valve which normally remains closed as fluid in the lower section of the pouch is collected and the walls thereof expanded.
Drainage appliances having the pouch construction as described above are generally useful in preventing backflow of fluid. However, the sealed construction of the inner sheets produces a barrier structure which has certain disadvantages. For example, immediately after an ostomy surgical procedure, it is normal post-operative practice to use drain tubes called stints while the stoma is healing. These tubes are inserted at their one ends into the stoma and the other ends are passed through the inlet opening in the pouch and down into the lower section of the pouch. With the sealed construction of the inner sheets, the drain tubes or stints must be snaked around the sealed area to reach the lower section of the pouch. These drain tubes are normally thin walled in construction and small in diameter. They can thus be readily kinked or squeezed closed by running into the sealed zone; and extreme care must be taken in directing the drain tubes into the pouch and in making sure that once in position they have not been damaged to the extent of restricting or precluding flow therethrough.
In addition to the above, prior art drainage appliances include an outlet spout and valve structure which presents problems in the area of clogging as the pouch is periodically emptied. Generally, the prior art outlet structures used with drainage appliances include a spout stem of rigid tubular construction having an opening therethrough of uniform circular cross-section. The spout stem is attached at one end of the lower section of the drainage appliance and a removable valve cap is provided for closing the outlet end of the spout. The spout and valve structure of this design has the disadvantage that it can become clogged during emptying due to the presence of mucous in the urine. This is especially so if the spout further includes any center support in the passageway. With this construction, it is also difficult to remove the cap from the spout and empty the pouch with assurance that this is neatly accomplished. Once the cap is removed and even when it is only partially removed, fluid starts to drain and there is no mechanical way of controlling it.
One final limitation of the present spout and valve structure is its ability to accommodate or be attached to external drainage conduits of varying construction. Attachment of the drainage appliances to external drains may, for example, be advantageous for night drainage or where the pouch is used in connection with a leg bag for wheel chair patients. External drain collection units of different manufacturers have different conduit constructions. Therefore, depending on which manufacturers' unit is used, it is generally necessary to provide a specially designed adapter to connect the unit to the spout of the pouch.